Table 5.
Clinical adverse event (AE) summary
| Number (%) of patients | Sitagliptin, N = 329 | Placebo, N = 329 | Difference in % vs. placebo (95% CIb) |
|---|---|---|---|
| With one or more | |||
| AE | 213 (64.7) | 230 (69.9) | −5.2 (−12.3, 2.0) |
| Drug-related AEa | 48 (14.6) | 73 (22.2) | −7.6 (−13.5, −1.7) |
| Serious AE | 13 (4.0) | 12 (3.6) | 0.3 (−2.8, 3.4) |
| Serious, drug-related AEa | 0 (0.0) | 0 (0.0) | 0.0 |
| Who died | 2 (0.6) | 1 (0.3) | 0.3 |
| Patients who discontinued | |||
| Due to AE | 6 (1.8) | 6 (1.8) | 0.0 (−2.3, 2.3) |
| Due to drug-related AEa | 4 (1.2) | 2 (0.6) | 0.6 (−1.1, 2.5) |
| Due to a serious AE | 0 (0.0) | 2 (0.6) | −0.6 |
| Due to serious drug-related AEa | 0 (0.0) | 0 (0.0) | 0.0 |
| Pre-specified AEs of interest | |||
| One or more | |||
| Adverse events of hypoglycemia | 93 (28.3) | 144 (43.8) | −15.5 (−22.7, −8.2) |
| Asymptomatic | 30 (9.1) | 53 (16.1) | −7.0 (−12.2, −1.9) |
| Symptomatic | 83 (25.2) | 121 (36.8) | −11.6 (−18.5, −4.5) |
| Severec | 10 (3.0) | 13 (4.0) | −0.9 (−4.0, 2.0) |
CI confidence interval
aDetermined by the investigator to be related to the drug
bComputed using the method of Miettinen and Nurminen [21], and provided only for endpoints occurring in at least four patients in one or both groups, per the pre-specified statistical analysis plan
cProtocol-specified definition of severe hypoglycemia: hypoglycemia requiring assistance, either medical or non-medical